St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resona... | NCT00631904

Studies
St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study

NCT00631904

Sponsor

Essentia Health

Status

Completed

Last Update Posted

Sep 2, 2011Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Mar 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Feb 29, 2008

First Submission Date that Met QC Criteria

Mar 7, 2008

First Posted Date

Mar 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2011

Last Update Posted Date

Sep 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans.

Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions.

Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI scanning, though the largest published study to date consists of 54 patients, and no long term follow-up has been published.

Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.

This study will evaluate patients with permanent pacemakers undergoing medically indicated MRI scanning.

Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB function, and myoglobin levels within the first 12 hours following the scans, side effects, symptoms, the need to make pacemaker program changes, and possible artifacts created by the pacemaker on the MRI scan.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Observation		Patients with permanent pacemakers undergoing medically indicated MRI scanning.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Any change greater than 1 volt at a pulse width of 0.5 ms in a pacemaker lead 12 months from an MRI scan		12 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiac troponin-I, creatine kinase, MB fraction, and myoglobin levels within the first 12 hours following the scans.		12 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Permanent pacemaker or ICD implanted for at least 6 weeks
Referred for medically indicated MRI
Age greater or equal to 18 years old

Exclusion Criteria:

ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm-2 MDT GEM-I series
Epicardial coronary sinus lead or subcutaneous array
Unable to program all leads to bipolar configuration
Pacemaker Dependent
Device has reached elective replacement or end of life
Other usual contraindications to MRI scanning
The use of inotropic pharmacological agents, such as dobutamine, during the MRI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Permanent pacemaker or implantable cardioverter-defibrillator (ICD) implanted for at least 6 weeks.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Mollerus, MD	Essentia Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Essentia Health		Duluth	Minnesota	55805	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3946261	Background	Erlebacher JA, Cahill PT, Pannizzo F, Knowles RJ. Effect of magnetic resonance imaging on DDD pacemakers. Am J Cardiol. 1986 Feb 15;57(6):437-40. doi: 10.1016/0002-9149(86)90768-x.
10831713	Background	Sommer T, Vahlhaus C, Lauck G, von Smekal A, Reinke M, Hofer U, Block W, Traber F, Schneider C, Gieseke J, Jung W, Schild H. MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. Radiology. 2000 Jun;215(3):869-79. doi: 10.1148/radiology.215.3.r00jn08869.